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<article xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:mml="http://www.w3.org/1998/Math/MathML" article-type="article-commentary"><?properties manuscript?><front><journal-meta><journal-id journal-id-type="nlm-journal-id">9805554</journal-id><journal-id journal-id-type="pubmed-jr-id">21009</journal-id><journal-id journal-id-type="nlm-ta">Sex Transm Infect</journal-id><journal-id journal-id-type="iso-abbrev">Sex Transm Infect</journal-id><journal-title-group><journal-title>Sexually transmitted infections</journal-title></journal-title-group><issn pub-type="ppub">1368-4973</issn><issn pub-type="epub">1472-3263</issn></journal-meta><article-meta><article-id pub-id-type="pmid">28778981</article-id><article-id pub-id-type="pmc">6748393</article-id><article-id pub-id-type="doi">10.1136/sextrans-2017-053301</article-id><article-id pub-id-type="manuscript">HHSPA1050475</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Role of dual HIV/syphilis test kits in expanding syphilis
screening</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Taylor</surname><given-names>Melanie M</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Peeling</surname><given-names>Rosanna W</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Toskin</surname><given-names>Igor</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Ghinidelli</surname><given-names>Massimo</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib></contrib-group><aff id="A1"><label>1</label>Department of Reproductive Health and Research, World
Health Organization, Geneva, Switzerland</aff><aff id="A2"><label>2</label>Department of STD Prevention, US Centers for Disease
Control and Prevention, Atlanta, Georgia, USA</aff><aff id="A3"><label>3</label>International Diagnostics Centre, London School of Tropical
Medicine and Hygiene, London, UK</aff><aff id="A4"><label>4</label>International Diagnostics Centre, Pan American Health
Organization, Washington, District of Columbia, USA</aff><author-notes><fn fn-type="con" id="FN1"><p id="P1"><bold>Contributors</bold> All the authors equally contributed to the
development, review and editing of the manuscript.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>13</day><month>9</month><year>2019</year></pub-date><pub-date pub-type="epub"><day>04</day><month>8</month><year>2017</year></pub-date><pub-date pub-type="ppub"><month>11</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>17</day><month>9</month><year>2019</year></pub-date><volume>93</volume><issue>7</issue><fpage>458</fpage><lpage>459</lpage><!--elocation-id from pubmed: 10.1136/sextrans-2017-053301--><related-article related-article-type="commentary-article" xlink:href="5739853" ext-link-type="pmcid" id="ra1" xlink:type="simple"/></article-meta></front><body><p id="P2">Screening pregnant women for HIV and syphilis is a critical component of national
programming to achieve elimination of mother to child transmission (EMTCT) for the two
diseases. Many countries have well-resourced programmes for HIV screening in pregnant
women and key populations (men who have sex with men and sex workers), but screening for
syphilis in these same risk groups is seldom centralised and often falls within the
responsibilities but outside the priorities of reproductive health, antenatal care and
sexually transmitted infection (STI) control programmes. The tragedy of babies avoiding
HIV and dying of syphilis and the lack of progress in Africa in congenital syphilis
elimination despite tremendous successes in EMTCT for HIV has once again reminded us of
the need to re-examine this situation.<sup><xref rid="R1" ref-type="bibr">1</xref><xref rid="R2" ref-type="bibr">2</xref></sup></p><p id="P3">In this issue, Obure <italic>et al</italic> describes a comparative analysis of
costs of single versus dual rapid diagnostic tests for HIV and syphilis in the cities of
Bogota and Cali in Columbia.<sup><xref rid="R3" ref-type="bibr">3</xref></sup> The
authors report higher costs associated with the use of rapid dual HIV/syphilis tests
compared to single rapid HIV and syphilis tests. At baseline, the Columbia purchase
price of the rapid dual test kits was more expensive than the single test kits; US$3.62
for the dual test versus US$2.26 for the two single tests (US$1.03 for single HIV and
US$1.23 for syphilis). A comprehensive diagnostic brief of rapid dual tests has recently
cited the average cost of US$1.50 per test kit.<sup><xref rid="R4" ref-type="bibr">4</xref></sup> Pan American Health Organisation&#x02019;s (PAHO) Strategic Fund
is offering the same rapid dual test kits for US$1.50 per test.</p><p id="P4">In the selection of diagnostic tests, country programmes face trade-offs between
accuracy, affordability and accessibility. Rapid dual HIV/syphilis tests are accessible
to the lowest levels of the healthcare system. In this case, however, only one dual
HIV/syphilis rapid test kit has been prequalified by WHO,<sup><xref rid="R5" ref-type="bibr">5</xref></sup> although others are in various stages of this
process.<sup><xref rid="R6" ref-type="bibr">6</xref></sup> As this is the only
rapid dual HIV-syphilis test prequalified by WHO, countries are not in a position to ask
for competitive pricing. So what other factors should be considered by Ministries of
Health?</p><p id="P5">Cost-effectiveness in terms of cost per woman screened and per adverse pregnancy
outcome averted would be an important consideration. In addition, efficiencies for the
healthcare systems gained by combining two tests in a single cartridge for a single
visit in terms of staff time and patient convenience. Practical considerations of using
a rapid dual HIV/syphilis test over two single tests include: streamlined purchasing,
storage, transport, waste management and savings incurred from halving the cost of
supplies.<sup><xref rid="R7" ref-type="bibr">7</xref></sup></p><p id="P6">Obure and colleagues recognised that costs per woman tested were higher in Bogota
as compared with Cali and noted that in Bogota where HIV and syphilis incidence were
lower, dedicated staff were not allocated to solely providing HIV and syphilis testing
services. This comment implies that staff in Bogota may be less familiar with delivering
HIV and syphilis testing possibly increasing time in delivery and interpretation of the
newly introduced rapid dual test. We also highlight inclusion of staff costs and the
finding of higher average time for delivery and interpretation of the rapid dual
HIV/syphilis test (29 min) versus the two single tests (25 min). We note that delivery
of two separate tests increases complexity in specimen collection and results
interpretation and would intuitively require more time.</p><p id="P7">We recognise the higher costs associated with the use of the rapid dual test in
this study but noted the authors&#x02019; acknowledgement that cost-effectiveness was not
evaluated. Prenatal syphilis screening is one of the most cost-effective health
interventions, and integrating syphilis screening alongside HIV screening improves this
more.<sup><xref rid="R8" ref-type="bibr">8</xref></sup></p><p id="P8">Recent analyses have demonstrated the cost-effectiveness of HIV and syphilis
screening using dual rapid diagnostics over single HIV and syphilis tests or HIV testing
alone. Of the antenatal testing algorithms in the analysis by Bristow <italic>et
al</italic>, a dual rapid diagnostic test was estimated to result in the lowest
number of adverse pregnancy outcomes and had the lowest overall costs.<sup><xref rid="R9" ref-type="bibr">9</xref></sup></p><p id="P9">A systematic review has shown that the field performance of rapid dual
HIV/syphilis tests are comparative to reference testing performed in the lab.<sup><xref rid="R10" ref-type="bibr">10</xref></sup> The added utility and feasibility of a
single platform for testing of multiple infections makes these tests attractive for use
among populations recommended for routine screening for both infections, particularly
pregnant women. The WHO recognises dual HIV/syphilis (multiplex) point of care
diagnostics as an option for HIV testing<sup><xref rid="R11" ref-type="bibr">11</xref></sup> and has released interim guidance on use and interpretation of
these tests pending a WHO-approved algorithm.<sup><xref rid="R7" ref-type="bibr">7</xref></sup></p><p id="P10">In 2007, WHO released the strategy for elimination of congenital
syphilis,<sup><xref rid="R12" ref-type="bibr">12</xref></sup> which stated as a
primary pillar the need for advocacy to improve coverage of syphilis testing in
pregnancy. This was followed in 2014 by the WHO global guidance on the processes for
country validation of EMTCT of both HIV and syphilis. This guidance sets as process
criteria for country validation of EMTCT; 95% coverage of antenatal care, 95% testing
coverage of pregnant women for HIV and syphilis and 95% treatment coverage for those
pregnant women testing positive for HIV or syphilis.<sup><xref rid="R13" ref-type="bibr">13</xref></sup> In 2016, WHO released the Global STI Strategy which calls for a
reduction of congenital syphilis rate to &#x0003c;50 cases per 100 000 live births in all
countries by 2030.<sup><xref rid="R14" ref-type="bibr">14</xref></sup> The delivery of
HIV and syphilis testing using a single testing platform offers countries an option to
improve both syphilis and HIV testing coverage in antenatal care in pursuit of EMTCT of
both infections. The combined platform offers the potential to leverage HIV testing
resources to purchase rapid dual test kits.</p><p id="P11">Obure <italic>et al</italic>, recently published a comparative effectiveness
evaluation<sup><xref rid="R15" ref-type="bibr">15</xref></sup> of rapid dual
tests versus single tests among the same sample of women and antenatal care service
centres in Columbia. They found no differences in patient acceptability, testing and
timely treatment.</p><p id="P12">A lower negotiated test kit cost in this study by Obure <italic>et al</italic>
would have reduced overall costs and may have led to different conclusions. Test kit
cost is a key factor in the uptake of rapid diagnostic tests. Volume purchasing and
leveraging HIV funds are options that should be considered by countries to cover this
upfront cost of rapid dual HIV/syphilis tests and maintain capacity to continue
integrated testing in antenatal care settings.</p><p id="P13">The anticipated improvements in syphilis screening coverage when aligned with
HIV through this novel test technology offer the opportunity to expand syphilis
screening in pregnancy, as well as key populations, and avert adverse birth outcomes
such as stillbirth and neonatal death which occur commonly to pregnant women with
untreated syphilis. This effect would be greatest in regions where maternal syphilis
morbidity is high and syphilis screening in pregnancy and in key populations is low such
as sub-Saharan Africa and some countries in South America and the Western Pacific.
Though cost-effectiveness studies evaluating the rapid dual HIV/syphilis test alongside
other testing strategies are limited, those that are available show benefit in use of
rapid dual test kits.<sup><xref rid="R8" ref-type="bibr">8</xref></sup> Additional
cost-effectiveness studies may provide more detail regarding the effect of improving
syphilis screening among pregnant women and key populations to reduce adverse birth
outcomes due to congenital syphilis.</p><p id="P14">To date, five countries in the PAHO region have been validated by WHO for EMTCT
of HIV and syphilis. Columbia and other PAHO countries continue to advance knowledge of
effective EMTCT strategies through evaluation of testing technologies such as rapid dual
HIV/syphilis testing in antenatal settings and achievement of validation
targets.<sup><xref rid="R3" ref-type="bibr">3</xref><xref rid="R15" ref-type="bibr">15</xref></sup> We encourage other countries to
support the use of rapid dual HIV/syphilis test kits and to evaluate cost effectiveness
in antenatal care settings and among key populations.</p></body><back><fn-group><fn id="FN2"><p id="P15" content-type="publisher-disclaimer"><bold>Disclaimer</bold> The views
expressed in this commentary are those of the authors and do not reflect the
position of the WHO or the US Centers for Disease Control and Prevention.</p></fn><fn fn-type="COI-statement" id="FN3"><p id="P16"><bold>Competing interests</bold> None declared.</p></fn><fn id="FN4"><p id="P17"><bold>Provenance and peer review</bold> Commissioned; internally peer
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